29

Mar

2017

Cl II Siemens ADVIA Centaur XPT System

0

Company: Siemens Healthcare Diagnostics, Inc
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient demographics and results. Siemens has identified multiple software issues affecting multiple versions of the software used by this analyzer system.
Recall Number Z-1537-2017

REASON
Siemens Healthcare Diagnostics has identified multiple software issues for all the ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. These issues may affect the operation and workflow of the system. The potential exists for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may potentially impact all analytes available on the ADVIA Centaur XPT System test menu.

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY on 2/2/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
US: 17 units; Foreign: 712 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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